Slenyto
- Prescription status not stated
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Melatonin
- Made by
- RAD Neurim Pharmaceuticals EEC SARL
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient. treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | RAD Neurim Pharmaceuticals EEC SARL |
|---|---|
| Active substance | Melatonin |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Classification | N05CH01 · Pain, sleep, mood, epilepsy and the brain |
| Authorised on | 2018-09-20 |
| Last updated by the regulator | 2026-06-10 |
| EMA product number | EMEA/H/C/004425 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.